510(k) · Cleared

Cleared

Validate Chem 8 Calibration Verification Test Set; Model 108

K020450510(k) TraditionalCleared Mar 21, 200238-day reviewClass I21 CFR 862.1660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Maine Standards Co. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Mar 21, 2002 as substantially equivalent to K881773 (Casco Standards, 1988) after a 38-day review. Its family tree reaches back 1 generation to 1988.

Decided: Mar 21, 2002
Review: 38 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K881773 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK881773 Document (TM) Direct Ise Linearity Test SetCasco Standards · 1988
This deviceK020450 Validate Chem 8 Calibration Verification Test Set; Model 108Maine Standards Co. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K881773	Document (TM) Direct Ise Linearity Test Set	Casco Standards	1988	—
0 (this device)	K020450	Validate Chem 8 Calibration Verification Test Set; Model 108	Maine Standards Co.	2002	—

FIG. 1 — Lineage of K020450, 1988–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K881773	Document (TM) Direct Ise Linearity Test Set Summary page 1 …8 Calibration Verification Test Set Common Name: Calibration Verification Classification Name: Calibrator, Multi-Analyte Predicate Device: DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics. Device description: VALIDATE Chem 8 Calibration Verification Test Set contains purified…	Casco Standards	1988	—

Also cleared against K881773: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K881773.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJY

2in 2025

2007high 6 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJY

13in 2025

2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

What is it indicated for?

The VALIDATE Chem 8 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems employing direct ion selective technology to measure the following analytes: lithium, sodium, potassium and chloride.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020450 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020450: Validate Chem 8 Calibration Verification Test Set; Model 108.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020450

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026